WuXi AppTec Attends FDA Workshop “Accreditation Scheme for Conformity Assessment (ASCA) of Medical Devices to FDA-Recognized Standards"

Posted by Yvonne Leonard, Director of Marketing on July 10, 2018

Our technical and regulatory experts actively participated in the workshop and its biocompatibility round table discussion.

The Federal Drug Administration (FDA) continues to focus on an approach to reduce the burden on medical device manufacturers with the goal to expedite time to market without jeopardizing regulatory oversight related to product safety. The agency’s latest program, Accreditation Scheme for Conformity Assessment (ASCA) of Medical Devices to FDA-Recognized Standards, was formed with this objective in mind.

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Topics: Medical Device, Biological Safety Testing, Regulatory, Scientific Director, biocompatibility, Technical Expertise

WuXi AppTec Names Mark Cunningham as Senior Director of Science and Technology

Posted by Yvonne Leonard, Director of Marketing on May 29, 2018

WuXi AppTec is pleased to announce that Mark Cunningham, Ph.D., has accepted the position of Senior Director of Science and Technology.

Dr. Cunningham brings more than 25 years of experience in the biopharmaceutical and contract research organization (CRO) industries supporting the R&D of pharmaceutical, biotech, medical device and combination products.

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Topics: Contract Research Organization, Medical Device, Preclinical Safety, Biological Safety Testing, Regulatory, Scientific Director, consultant, Technical Expertise

WuXi AppTec Names former FDA Commissioner’s fellow as a Senior Scientific Director

Posted by Yvonne Leonard, Director of Marketing on May 01, 2018

We are pleased to announce that Li Yang, Ph.D., DABT, has joined our team as a Senior Scientific Director in WuXi AppTec Laboratory Testing Division’s Medical Device Consulting Group.

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Topics: Regulatory, FDA, Scientific Director, consultant